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The Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.

The Medline ReNewal Reprocessed Carter-Thomason Suture Passer Set (models CTI-512N, CTI-1015N, PG-15S, and PG-5/10) is a sterile, single-case use, hand-held suture grasping device that is designed to pass suture through soft tissue.

The provided text describes a 510(k) submission for a reprocessed medical device, the "Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Instrument Set." This submission aims to prove substantial equivalence to an existing predicate device, not necessarily to meet specific performance criteria as one might find for novel AI/software as a medical device (SaMD) products.

Therefore, the structure of the acceptance criteria and the study that proves the device meets them will differ significantly from what would be expected for an AI-based diagnostic tool. The "acceptance criteria" here are based on demonstrating that the reprocessed device performs functionally identically and safely to the original, legally marketed device.

Here's an analysis based on the provided text, using the requested categories where applicable:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a quantitative table of acceptance criteria with specific numerical thresholds for performance metrics. Instead, it describes a series of tests conducted to demonstrate equivalence. The "acceptance criteria" are implicitly that the reprocessed device performs equivalently to the original device in key functional and safety attributes.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the number of individual reprocessed devices tested for each category (e.g., how many devices were subjected to simulated use, or cleaning tests). It simply lists the types of tests performed.
• Data Provenance: Not explicitly stated regarding the origin of the reprocessed devices used for testing (e.g., country of origin of the used devices before reprocessing). The tests are described as being performed by the reprocessor, Medline ReNewal. The nature of the study is retrospective in the sense that existing used devices are collected for reprocessing and subsequent testing, although the testing itself is prospective on those reprocessed units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this device type and submission. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is primarily relevant for diagnostic devices (especially AI/SaMD). For a reprocessed surgical instrument, the "ground truth" is its functional performance and safety profile, which is established through objective, standardized engineering and biological testing, not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers or algorithms interpret data and discrepancies need to be resolved. For evaluating the physical and biological properties of a reprocessed surgical instrument, such methods are irrelevant. Test results are based on objective measurements against predefined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical data (e.g., radiologists reading X-rays). This device is a surgical instrument used to pass suture, not a diagnostic tool, and involves no "human readers" in the context of interpretation or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this reprocessed device is established through:

• Engineering Performance Specifications: The device must meet the original manufacturer's specifications for mechanical function, integrity, and dimensions.
• Cleaning Efficacy Standards: Demonstrated by the absence of significant biological residues.
• Sterility Assurance Levels: Proven through sterilization validation.
• Biocompatibility Standards: Proven through direct testing on the reprocessed materials.

These are objective, measurable criteria, not subjective interpretations requiring expert consensus or pathology, nor are they based on patient outcomes data for the pre-market submission (though post-market surveillance would track adverse events).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI model, this question is irrelevant to the reprocessing of a surgical instrument.

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